Retrospective evaluation of occurrence of skin injuries in interventional cardiac procedures.

Interventional cardiology procedures can involve high doses to patients and, in particular, to patients' skin, the tissue at greatest risk of deterministic injuries. The evaluation of skin dose from interventional procedures is recommended, but difficult because of the amount of different X-ray fields and projections used in a procedure. For this reason, a retrospective follow-up study has been developed to identify skin injuries in patients submitted to one or more cardiac interventions in the Udine hospital between 1998 and 2002. Seventy-eight patients with a cumulative dose-area product >300 Gy cm2 were selected from 3332 patients, who underwent 5039 procedures. In this group the maximum skin dose was 6.7 Gy. The clinical follow-up, performed using the LENT-SOMA methodology, has not detected skin injuries and this result allows a frequency to be estimated for skin injuries in patients undergoing repeated cardiac procedures of <3 x 10(-4) in our centre.

A study to validate the method based on DIMOND quality criteria for cardiac angiographic images.

A method based on image quality criteria (QC) for cine-angiography was developed to measure the quality of cine-angiograms (CA). A series of 30 CA for left ventriculography (LV) and left and right coronary angiography (LCA, RCA) have been scored and 172 readings were obtained. Standard deviation of quality scores indicated the reproducibility of the method. Each part of CA was examined separately, giving scores for LV, LCA and RCA and a total score (TS), with clinical (C) and technical (T) criteria defined and examined separately. In 83% of the studies TS was >0.8 and with standard deviation from 0.02 to 0.21. In general, LV had a lower score and greater disagreement compared with RCA and LCA. Disagreement was greater in T, compared with C. In conclusion, these results indicate that QC, translated into a scoring system, yields reproducible data on the quality of cardiac images.

Intraoperative transesophageal echo-Doppler evaluation of stentless aortic xenografts. Incidence and significance of moderate gradients.

BACKGROUND: The aim of this study was to assess the utility of intraoperative transesophageal echocardiography (TEE) in the evaluation of patients undergoing aortic valve replacement with the CryoLife-O'Brien (CLOB) Stentless Porcine Aortic Bioprosthesis. METHODS: Between May 1994 and March 1995, 26 patients (15 men, mean age 68.4+/-10.78 years) had a CLOB valve in the aortic position. Transprosthetic gradients and valve regurgitation were detected by intraoperative TEE. Prosthetic regurgitation and transvalvular gradients were evaluated at six-month intervals using transthoracic echo-Doppler (TTE). RESULTS: The majority of implants resulted in low gradients (83.7%), with only four patients exhibiting a moderate gradient (15.3%). Color flow Doppler imaging showed central aortic regurgitation in only four of 25 patients (trivial, n=4; mild, n=1). There was one paravalvular leak (trivial, n=1). At follow-up examination (mean 37+/-12 months), 24 of 25 patients exhibited low mean gradients (7.25+/-2.81 mmHg). At follow-up one patient who had low velocities in the LVOT at perioperative evaluation exibited a moderate gradient (45 mmHg) with an effective orifice area of 0.8-0.9 cm(2). CONCLUSIONS: Intraoperative TEE was effective in assessing prosthetic stentless valve function.

Stentless aortic valve replacement in elderly patients.

OBJECTIVE: Seven-year clinical and hemodynamic results of the Cryolife O'Brien (CLOB) stentless bioprosthesis in elderly patients are reported. METHODS: From 1993 to 2000, 36 patients aged >75 years had a CLOB implanted in the aortic position. Eighteen (50%) were male. All patients were monitored with serial echocardiograms performed preoperatively, at discharge, six months, one year and yearly thereafter. RESULTS: The 30-day mortality was 2.4% (1/36). Actuarial survival at one, five and seven years were 96.7+/-1.5, 94.8+/-2.0 and 94.8+/-2.0%, respectively. Peak and mean gradients (PG and MG) reduced and effective orifice area index (EOAI) increased over time (P<0.001). Left ventricular mass index (LVMI) reduced by 32 g/m2 at discharge (P<0.001) and by 33 g/m2 at six months (P<0.001) without further significant changes. CONCLUSIONS: In our series CLOB xenograft resulted to be a satisfactory valve substitute in elderly patients.

"Side balloon stenting": a novel technique for bifurcation lesions.

We describe a new technique to treat stenoses of coronary bifurcations. The aim of this technique, called "side balloon stenting," is to treat the bifurcation lesions with the kissing balloon technique, implanting one or more stents without removing the guidewires which remain in place during the whole procedure, avoiding potential problems of access to the vessels jailed by stent struts. In addition, implanting the stent using the kissing balloon technique would prevent the "snow-plow" phenomenon (plaque shifting) in the side branch. The "side balloon stenting" technique was applied in 29 cases at various levels of coronary artery segments involving bifurcations (Table 1). The technical success rate of the side balloon stenting was 90% (25 procedures). The elective placement of one stent in the main vessel was done in 20/25 procedures (80%), and in only 5/25 (20%), it was also necessary to insert a second one in the side branch (due to suboptimal results), using the "culotte" technique in two and the T-technique in the other three. We were unable to advance the system to the right position in 4 patients (13%): in 2 due to twisting of the guidewires and in the other due to vessel tortuosity and insufficient backup of the system (guiding catheter and guidewires). In these four last cases, the delivery system was retrieved and a stent was successfully implanted in the right position in the main branch. Angiographic success (residual stenoses < 30% and TIMI 3 flow in both branches) was obtained in 100% of the cases. The post-intervention period was uneventful. These preliminary results show that the side balloon stenting technique is both feasible and safe in th treatment of coronary bifurcations with a satisfactory rate of procedural success and often (82%) positioning only one stent in the parent vessel, thus avoiding stenting the side branch. It will be necessary, however, to assess, based mainly on restenosis rate, whether these promising immediate results will persist in the long run.

Left ventricular mass regression after aortic valve replacement with CryoLife-O'Brien stentless aortic bioprosthesis.

BACKGROUND AND AIM OF THE STUDY: Left ventricular (LV) hypertrophy has been shown adversely to affect LV function and late outcome after aortic valve replacement (AVR). The study aim was to assess the time course of LV mass regression (LVMR) after AVR with a CryoLife-O'Brien stentless bioprosthesis, and to identify factors affecting late reduction of myocardial hypertrophy. METHODS: In total, 113 patients (60 males, 73 females; mean age 70.9+/-6.5 years) were studied by echocardiography preoperatively, at discharge, at six and 12 months postoperatively, and yearly thereafter. LV diameter and thickness were measured using M-mode echocardiography; LV mass was calculated using the Devereux formula and indexed by body surface area (BSA). RESULTS: LV end-systolic diameter, end-diastolic diameter, septal thickness and wall thickness decreased significantly after surgery (p <0.001). LV mass index (LVMI) was reduced by 16.6, 13.6, 10.1, 3.1, 3.3, 1.7, 2.6, and 1.8% at discharge and at 6 months and 1, 2, 3, 4, 5, and 6 years, respectively. Most LVMR occurred within the first year, with further (not significant) reductions at later examinations. Male sex (p = 0.002), arterial blood pressure > or =150 mmHg (p <0.001), LV ejection fraction (LVEF) < or =35% (p = 0.01), NYHA functional class > or = III (p = 0.01), atrial fibrillation (p <0.001), mean transvalvular gradient > or =40 mmHg (p = 0.001), and prevalent aortic incompetence (p <0.001) were factors influencing LVMR, independently of baseline effective orifice area and prosthesis size. CONCLUSION: AVR with the CryoLife-O'Brien stentless prosthesis resulted in significant LVMR. These findings encourage the use of this bioprosthesis in appropriate patients.

Quality criteria for cardiac images in diagnostic and interventional cardiology.

The quality of cardiac imaging plays a pivotal role in clinical decision-making and depends mainly on the technical performance of the imaging system and on angiographic technique. The Italian Society of Invasive Cardiology and The Italian Society of Physics in Medicine have set quality criteria giving precise guidelines regarding how an angiogram should appear provided that good equipment and correct angiographic technique are used. The criteria have been reviewed by the European Concerted Action DIMOND Cardiology group and are reported here to provide a reference standard for images for the most common procedures in daily practice.

Time course of left ventricular remodeling after stentless aortic valve replacement.

BACKGROUND: Stentless aortic valves are associated with a significant decrease in left ventricular hypertrophy. This study examined the time course and factors affecting left ventricular mass regression (LVMR) after aortic valve replacement (AVR) with Cryolife O'Brien (CLOB) (Cryolife International, Atlanta, Ga) stentless valves. METHODS: Between 1993 and 2000, 130 consecutive patients underwent AVR with CLOB. Mean age was 71.3 +/- 6.3 years. Sixty-four (49.2%) were male. Mean body surface area (BSA) was 1.7 +/- 0.2 m(2). Mean valve size implanted was 23.6 +/- 2.0 mm. All patients were monitored with serial echocardiograms; the first study was performed preoperatively, and subsequent controls were at 6 months, 1, 2, 3, 4, 5, 6, and 7 years, respectively. Left ventricular mass was calculated by the Devereux formula and indexed by BSA. RESULTS: Analysis of variance showed a significant reduction in the left ventricular mass index (LVMI) over time (P < .001). Most LVMRs occurred within the first 6 months, and after 1 year LVMI had decreased by 37.5% with further, but not statistically significant, reductions at later examinations. We found that baseline BSA > 1.75 m(2), male sex, arterial blood pressure > or = 150 mm Hg, left ventricular ejection fraction < or = 35%, New York Heart Association functional class > or = III, non-sinus rhythm, and prevalent aortic incompetence to be factors influencing LVMR. LVMR was not related to postoperative effective orifice area < or = 0.85 cm/m(2) and prosthetic size. CONCLUSIONS: AVR with a CLOB valve is followed by a significant LVMR that occurs soon after surgery. It is influenced by several patient-related factors: most of them can be predicted preoperatively.

A method based on DIMOND quality criteria to evaluate imaging in diagnostic and interventional cardiology.

Image quality criteria (IQC) for cine-angiography were recently settled. The aim of this study was to test whether these criteria allow a measurement of the quality of cine-angiograms. A questionnaire was derived from IQC where a binary response was required regarding the degree of visibility of anatomic or pathologic structures. Scores were given on a ranking scale. Two quality scores were defined (total score and minimum score) and standard deviation (SD) was assumed to be an indicator of the method's reproducibility. Data of the total score are presented for the first nine angiograms. Six experts obtained thirty-nine readings. The total scores ranged between 83 and 99% (SD 0.8-18.7%); 89% of the readings were within 4% of SD. This preliminary experience indicates that quality criteria can be translated into a scoring system that yields reproducible data in most instances. The analysis of the remaining angiograms will help in understanding how to improve these results.

Patient dose related to the complexity of interventional cardiology procedures.

In interventional cardiology (IC) the PTCA (percutaneous transluminal coronary angioplasty) procedure is the most frequent procedure with the highest dose to the patient. The procedure is usually performed by cardiologists having, in general, insufficient knowledge of radiation physics, radiation technology and radiation protection. The need for radiation protection is of paramount importance in this field of interventional radiology. Correlation between the complexity of PTCA procedure and irradiation parameters (fluoroscopy time, number of images and dose-area product--DAP) has been demonstrated. The presence of severe tortuosity and occlusion of > or = 3 months play a major role. Fluoroscopy time is better correlated with technical factors than DAP, which also includes the influence of patient size, collimation, operation modes, and X ray beam orientation. The number of acquired images is less correlated with the complexity of the PTCA procedure. A complexity index was conceived and procedures were divided into three groups, defined as: simple, medium and complex, which were significantly different in terms of patient dose.

Early and midterm results of model 300 CryoLife O'Brien stentless porcine aortic bioprosthesis.

BACKGROUND: The Cryolife O'Brien (CLOB) is a composite stentless bioprosthesis constructed from noncoronary leaflets of three porcine aortic valves. This study aimed to investigate early and midterm results after aortic valve replacement with CLOB xenograft. METHODS: Between 1993 and 2000, the CLOB was implanted in 125 patients (62 men; mean age 71.3+/-6.4 years). Mean prosthesis size was 23.6+/-2 mm. Mean follow-up time was 37.0+/-12.1 months. Patients underwent echocardiographic studies preoperatively, at discharge, at 6 and 12 months postoperatively, and yearly thereafter. RESULTS: Early (30-day) mortality rate was 2.4% (3 of 125 patients). Of the four late deaths, none was valve related. Actuarial 7-year survival was 93.6%+/-3%. Seven-year freedom from primary valve failure was 98.1%+/-1.8%. All patients showed an improvement of functional status (p < 0.001). ANOVA revealed a significant reduction over time in peak and mean systolic gradients (p < 0.001). Effective orifice area index increased (p < 0.001) and left ventricular mass index significantly reduced in all valve sizes (p < 0.001) during this time interval. CONCLUSIONS: Because the early and midterm results with CLOB xenograft have been satisfactory, we encourage its use as a valve substitute, particularly in patients with small aortic roots.

Coronary artery bypass grafting in patients with dialysis-dependent renal failure: ten-year results.

BACKGROUND: Coronary artery disease has been reported to be accelerated in patients with chronic renal failure on maintenance dialysis. Coronary artery bypass grafting (CABG) in patients on long-term dialysis is still a debated issue. METHODS: We retrospectively reviewed 19 patients (12 men, 7 women, mean age 64 +/- 11.2 years) with end-stage renal disease who underwent CABG between 1990 and 2000. Operative procedures were CABG alone in 15 (78.9%) patients and CABG associated with valve procedures in 4 (21.1%) patients. RESULTS: The early (30-day) mortality rate was 10.5% (2 of 19 patients). Non-fatal complications occurred in 6 patients (31.5%). Four delayed deaths occurred; the actuarial survivals at 1, 2, 5 and 10 years were 0.86 +/- 0.14, 0.78 +/- 0.10, 0.68 +/- 0.13 and 0.54 +/- 0.15 respectively. Among 13 survivors the mean Canadian Cardiovascular Society class was 1.3 +/- 0.3 (p < 0.001 vs preoperatively). ANOVA procedures showed age (p = 0.01), Canadian Cardiovascular Society class > or = III (p < 0.001), urgent/emergency operation (p < 0.001), left ventricular ejection fraction < 0.50 (p < 0.001), a prior myocardial infarction (p = 0.01), a preoperative mean creatinine level > or = 5 mg/dl (p = 0.02) and a duration of dialysis > or = 60 months (p = 0.03) to be strongly related to early and delayed mortality. CONCLUSIONS: CABG in patients with dialysis-dependent chronic renal failure is associated with acceptable results. Accurate patient selection, early referral to surgery, and adequate perioperative management are advisable.

The CryoLife O'Brien stentless porcine aortic bioprosthesis: 5-year follow-up.

BACKGROUND: Mortality, morbidity, complication rates, and echo hemodynamic results using the Cryolife O'Brien stentless aortic bioprosthesis over a 5-year period are reported. METHODS: The stentless valve was implanted in 97 conscecutive patients, 54 male and 43 female, mean age 70.9 +/- 6.5 years. All patients underwent preoperative, discharge (early study), 6-month (intermediate study), and late (18.3 +/- 10.4 months) echocardiography. RESULTS: The actuarial 5-year survival rate was 93.9% +/- 3%. Aortic regurgitation was absent in 95.5%, mild in 3.4%, and moderate in 1.1%. Peak and mean systolic gradients were significantly lower at discharge (p < 0.001) and at the 6-month follow-up (p < 0.001) but did not significantly fall further at the late study (p = NS). The effective orifice area index at discharge (p < 0.001) and at 6 months (p < 0.001) differed significantly from preoperative values, but variations at late study were not significant (p = NS). Left ventricular mass index decreased early postoperatively (p < 0.001) and at 6-month assessment (p < 0.001) with a further significant reduction at late echocardiography (p = 0.04). CONCLUSIONS: The 5-year results of this stentless valve showed a low rate of valve-related complications with excellent hemodynamic performance in all valve sizes.

Early recovery of left ventricular function after stentless versus stented aortic valve replacement for pure aortic stenosis and severe cardiac dysfunction.

OBJECTIVE: The aim of this study was to evaluate early recovery of systolic function after stentless aortic valve replacement (AVR) versus stented AVR. METHODS: Fifty-four consecutive patients with pure aortic stenosis and impaired left ventricular function (LVEF < or = 35%) were studied retrospectively. Aortic regurgitation, concomitant valvular or coronary artery surgery, atrial fibrillation, and a previous AVR were exclusion criteria. Twenty-two patients (mean age, 70.0 +/- 6.5 years) received a stentless bioprosthesis and 32 (mean age, 58.9 +/- 6.2 years, P =.031 between groups) a mechanical or stented biologic valve. Patients underwent echocardiography preoperatively, at discharge, at 6 months, and at 1 year after surgery. RESULTS: At 6 months, analysis of variance demonstrated significant differences between groups in fractional shortening measured at the endocardium and midwall fractional shortening (<0.001), velocity of circumferential shortening (P <.001) ejection fraction (P =.02), left ventricular mass index (P <.001), systolic meridional wall stress, and circumferential wall stress (P <.001), One-year studies confirmed these findings. CONCLUSION: LV function showed, after a stentless AVR, an early recovery greater than in patients receiving a stented valve.

Open heart surgery in patients with dialysis-dependent renal insufficiency.

OBJECTIVE: Chronic renal failure (CRF) is commonly considered a significant factor for increased morbidity and mortality after cardiac surgery. METHODS: To assess the risk in our population we retrospectively analyzed 28 patients (16 men and 12 women, mean age 58.1+/-10.8 years) with end-stage renal disease (ESRD) undergoing cardiac surgery between 1989 and 2001. Sixteen (57.2%) patients had isolated coronary artery bypass grafting (CABG), nine (32.1%) had isolated valve replacement, and three (10.7%) underwent combined CABG and valve replacement. Preoperatively, 20 (71.4%) patients were on hemodialysis and eight (28.6%) on peritoneal dialysis. Mean preoperative duration of dialysis was 38.7+/-24.9 months (range, 3 to 93 months). RESULTS: There were two perioperative deaths (30-day mortality, 7.1%). Actuarial survival at 1, 2, 5, and 12 years was 0.85+/-0.7, 0.73+/-0.10, 0.65+/-0.12, and 0.54+/-0.14, respectively. Among 22 survivors, mean NYHA class was 1.7+/-0.8 (p < 0.001 vs. preoperatively) and mean CCS class was 1.6+/-0.6 (p < 0.001 vs. preoperatively). CCS/NYHA functional class IV (p = 0.01), urgent/emergency operation (p < 0.001), LVEF < 35% (p < 0.001) were strongly related to early and late mortality. CONCLUSIONS: Open-heart operations can be performed with acceptable short- and long-term results in patients with CRF on dialysis. Adequate preoperative management with identification of high-risk patients and a more aggressive approach before the onset of symptoms of cardiac failure are advisable.

Clinical and hemodynamic evaluation of 21 mm and 23 mm Cryolife-O'Brien stentless bioprostheses implanted in the aortic position.

BACKGROUND: The aim of this study was to investigate early and mid-term results after aortic valve replacement with Cryolife-O'Brien stentless bioprosthesis, model 300. METHODS: Records of 59 patients who received a 21 or 23 mm (Group A) aortic Cryolife-O'Brien stentless valve were retrospectively reviewed and compared to 54 patients who received a valve > or = 25 mm (Group B). Group A patients were mainly female (p < 0.001), were older (p = 0.034), had dominant aortic stenosis (p = 0.011), and a smaller (p < 0.001) body surface area. Effective orifice area index was larger (p = 0.041) and left ventricular mass index higher (p = 0.024) in Group B. RESULTS: The actuarial survival at 5.5 years was 94.9 +/- 2.3% and 92.5 +/- 4.3% in Group A and B respectively (p = NS). The actuarial freedom from all events was 85.1 +/- 6.1% and 88.2 +/- 5.2% in Group A vs Group B respectively (p = NS). At late echocardiographic studies performed between 4 and 42 months (mean 27.3 +/- 6.1 months) postoperatively, peak and mean gradients decreased and effective orifice area index increased over the follow-up period (p = NS between groups). Left ventricular mass index decreased by 25% (p < 0.001) in Group A and by 20% (p < 0.001) in Group B from preoperatively and a further 13% (p = 0.034) and 8.5% (p = 0.004), respectively, from the early to the late study. No significant difference in left ventricular mass regression was noticed between groups (p = NS). CONCLUSIONS: The Cryolife-O'Brien porcine stentless bioprosthesis showed satisfactory mid-term results and may represent a good choice for patients with a small aortic annulus selected for a biological valve.

Clinical and technical determinants of the complexity of percutaneous transluminal coronary angioplasty procedures: analysis in relation to radiation exposure parameters.

Few data are available on the quantitative assessment of complexity (C), especially in relation to a patient's exposure to radiation. The relationship between several clinical (CFs), anatomic (AFs), and technical factors (TFs) versus fluoroscopy time (FT) was evaluated in 402 random percutaneous transluminal coronary angioplasty (PTCA) procedures. CFs were age, sex, single or multivessel disease, ejection fraction, and previous coronary artery bypass graft. AFs were assessed based on the American Heart Association / American College of Cardiology classification. TFs were multivessel PTCA, use of the double wire or double balloon technique, stenting, ostial stenting, bifurcation stenting, and intravascular ultrasonography. No CFs significantly influenced FT, whereas all AFs and TFs (except multivessel PTCA) did significantly influence FT. A scoring system was developed, and two complexity indexes (CI) were conceived, based on which the procedures were divided into three groups: simple, medium, and complex. The mean FTs were 471+/-289, 805+/-532, and 1,190+/-641 (P <0.0001), respectively. Total cine frame recordings were 1,119+/-572, 1,265+/-644 (P = 0.0355), and 1,418+/-785 (P<0.0001 vs. simple; P = NS vs. medium). The dose/area product measurement was 65.8+/-41.4, 93 +/-58.5 (P<0.0001), and 116.7+/-72.8 (P<0.0001 vs. simple; P = 0.00159 vs. medium), respectively. In our series, CI was directly related to AF and TF, but not to CF. Comparison of PTCA procedures and definition of appropriate FT should consider CIs.